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Phase III comparison of new versus current Infanrix Hexa formulation in healthy infants
2012-002427-15Phase 3
- Sponsor
- GSK
- Start
- Jun 2015
- Modality
- Whole Inactivated Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial of pertussis filamentous haemagglutinin and diphtheria toxoid + tetanus toxoid + acellular pertussis + hepatitis B recombinant + inactivated poliovirus vaccine in diphtheria, Tetanus, pertussis and 3 more (3 arms), sponsored by GSK. Primary endpoints: Seroprotection status and Non-inferiority of immunogenicity.
02
Drugs
pertussis filamentous haemagglutinindiphtheria toxoid + tetanus toxoid + acellular pertussis + hepatitis B recombinant + inactivated poliovirus vaccine
03
Conditions
diphtheriaTetanuspertussishepatitis B (HBV)poliomyelitis
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